Information About Losec 20mg Bottle Cap:
What the medicinal composition?
Each capsule contain: Omeprazole 20mg as enteric coated pellets.It is the research product of omeprazole.
Pharmaceutical form
Losec 20mg cap is hard gelatin capsule with and opaque pink body, marked 20 and opaque reddish brown cap marked A/OM.
What the medicine is used for?
Losec is indicated for the treatment of:
- Duodenal ulcer
- Gastric ulcer
- NSAID associated gastric and duodenal ulcer or erosions
- Reflux esophagitis
- Symptomatic gastro-esophagitis reflux disease
- Zollinger-Ellison syndrome
Posology of administration:
Losec capsules are recommended to be given in the morning and swallowed whole with half glass of water. The capsules should not be chewed or crushed.
Swallowing difficulties for patient
The capsule can be opened and the contents swallowed directly with half glass of water or mixing the contents in a slightly acidic fluid e.g. fruit juice or applesauce, or in carbonated water. The dispersion should be taken immediately or within 30 minutes. Always stir just before drinking. Rinse it down with half glass of water.
Duodenal ulcer
The recommended dosage in patient with an active duodenal ulcer is losec 20mg once daily. Symptoms resolution is rapid and in most patient healing occurs within 2 weeks . For those patient who may not be fully healed after the initial course, healing usually occurs during a further 2 weeks treatment period.
Gastric ulcer
The recommended dosage is losec 20mg once daily. Symptom resolution is rapid and in most patient healing occurs within 4 weeks.For those patient who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period.
NSAID associated gastric and duodenal ulcer or erosions
The recommended dosage is losec 20mg once daily. Symptom resolution is rapid and in most patient healing occurs within 4 weeks.For those patient who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period.
Helicobacter pylori (HP) eradication regiments in peptic ulcer
Triple therapy pigments: Losec 20mg, amoxicillin 1g and clarithromycin 500mg, all twice a day for one week.
Losec 20mg, metronidazole 400mg (or tinidazole 500mg, and clarithromycin 250mg all twice a day for one week.
Dual therapy pigments: Losec 40mg-80mg , amoxicillin 1.5g daily in divided doses for one week.
Reflux esophagitis
The recommended dosage is losec 20mg once daily. Symptom resolution is rapid and in most patient healing occurs within 4 weeks.For those patient who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period.
Symptomatic gastro-esophagitis reflux disease
The recommended dosage is Losec 20mg daily. Symptom relief is rapid. if symptom control has not been achieved after 4 weeks treatment with Losec 20mg daily, further investigation is recommended.
Zollinger-Ellison syndrome
In patient with zollinger-Ellison syndrome the dosage should be individually adjusted and treatment continued as long as is clinically indicated. The recommended initial dosage is losec 6omg Daily. All patient with serve disease and inadequate to other therapies have been effectively controlled and more than 90% of the patients maintain on doses of losec 20-120mg daily. when doses exceeds losec 80mg daily the dose be divided and given twice daily.
Impaired renal function
Dose adjustment is not needed in patients with impaired renal function.
Impaired hepatic function
In patient with impaired hepatic function a daily dose should not exceed 20mg.
Children
Losec 20mg capsules are not approved for use in children.
What is Works?
Losec works as a proton pump inhibitor (PPI) that reduced the amount of acid made in your stomach.
Special warning and special precaution for use
In the presence of any alarm symptoms (e.g. significant unintentional weight lose, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.
Pregnancy and lactation
Pregnancy: well conducted epidemiological studies indicate no adverse effects of omeprazole on pregnancy or on the health of the fetus/newborn child. Omeprazole can be used during pregnancy.
Lactation: Omeprazole is excreted in breast milk, influence, if any, on the child is unknown.
Effects on ability to drive and use machine
Losec is not likely to affect the ability to drive or use machine.
Undesirable effects
The most common side effects (1-10% of patient) are headache, abdominal pain, constipation, diarrhoea, flatulence, and nausea/vomiting.
Overdose
There is limited information available on the effects of overdose of omeprazole in humans. In the literature, doses of up to 560mg have been described,and occasional reports have been received when single oral doses have reached up to 2400mg omeprazole (120 times the usual recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache have been reported. Also apathy, depression and confusion have been described in single cases.
Pharmacokinetic Properties
Absorption: Omeprazole and omeprazole magnesium are acid and therefore administered orally as enteric-coated granules in capsules or tablets. Absorption omeprazole is rapid, with peak plasma levels occurring approximately 1-2 hour after dose. Absorption of omeprazole takes place in the small intestine and is usually completed within 3-6 hours.
Distribution: The apparent volume of distribution in healthy subjects is approximately 0.3 l/kg body weight. Omeprazole is 97% plasma bound.
Excretion: The plasma elimination half-life of omeprazole is usually shorter than one hour both after single and repeated oral once-daily doing. Omeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration. Almost 80% of an oral doses of omeprazole is excreted as metabolism in the urine, the reminder in the faeces, primarily originating from bile secretion.
List of excipients
Disodium hydrogen phosphate dihydrate, low substituted hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, mannitol, methacrylic acid copolymers, microcrystalline cellulose, macrogol (polyethylene glycol) sodium lauryl sulphate, iron oxide (E 172), titanium dioxide ( E 171) and gelatine.
Storage and instruction
- The capsule should be swallowed with liquid.
- Do not chew or crush capsule content.
- Use within 3 months, after opening the bottle,
- Replace cap firmly after use.
- Store below 30'C. Keep out of reach of children.
- Protect from light and moisture or as directed by physician.
Manufactured by
Astrazeneca (Cheplapharm Arzneimittel Gmbh, Ziegelhof 24, 17489 Greifswald, Germany.
Marketed By (In Pakistan)
Barret Hodgson Pakistan Pvt LTD.
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